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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-04437 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18-001776 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center |
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This phase I trial studies the impact of monosodium glutamate (MSG) on 68GA-PSMA-11 PET/CT in decreasing the salivary glands uptake in patients with prostate cancer. Prostate specific membrane antigen (PSMA) is a molecule that is overexpressed by the prostate cancer cells. 68GA-PSMA-11 is an imaging radioactive drug that can target this molecule in tissues for imaging and therapy of prostate cancer. Food substances, such as monosodium glutamate, may reduce salivary gland uptake of 68GA-PSMA-11. Ultimately, giving MSG may reduce potential harm and injury to the salivary glands in patients with prostate cancer treated with PSMA-targeted molecular radiotherapy.
PRIMARY OBJECTIVE:
I. To determine the effect of monosodium glutamate (MSG) administration (glutamate supplementation) on the salivary gland uptake of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11).
SECONDARY OBJECTIVES:
I. To determine the effect of MSG administration on renal 68Ga-PSMA-11 uptake. II. To determine the effect of MSG administration on tumor 68Ga-PSMA-11 uptake. III. To determine if 68GA-PSMA-11 is excreted in the saliva. IV. Safety of MSG administration both oral ingestion and oral-salivary stimulation.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and undergo a positron emission tomography (PET)/computed tomography (CT) scan on day 1. Within 2 weeks (days 2-14), patients receive MSG orally (PO) over 10 minutes and receive a second dose of gallium Ga 68-labeled PSMA-11 IV, followed by a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
Arm II: Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive a second dose of gallium Ga 68-labeled PSMA-11 IV immediately followed by MSG applied in the mouth over 30 seconds every 10 minutes for a total of 6 times, and then undergo a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (68GA-PSMA-11, PET/CT, monosodium glutamate) | Experimental | 8 patients receive gallium Ga 68-labeled PSMA-11 IV and PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive MSG PO over 10 minutes and receive a second dose of gallium Ga 68-labeled PSMA-11 IV, followed by a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT. |
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| Arm II (68GA-PSMA-11, PET/CT, monosodium glutamate) | Experimental | 8 patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive a second dose of gallium Ga 68-labeled PSMA-11 IV immediately followed by MSG applied in the mouth over 30 seconds every 10 minutes for a total of 6 times, and then undergo a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of saliva |
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| Measure | Description | Time Frame |
|---|---|---|
| Salivary gland uptake of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) | Standard uptakes values (SUV) values (maximum SUV [SUVmax] and SUVmean) in all assessable salivary glands will be measured with a spherical volume-of-interest with and without the administration of monosodium glutamate (MSG) interventions. SUVmax/salivary gland will be calculated and a mean SUVmax/patient will be generated. The aim is to show a 2-fold reduction of the salivary gland 68Ga-PSMA-11 uptake after MSG administration. Paired T-test will be used to determine statistical significance per salivary gland and per patient. | 2 measurements within 2 to 14 days maximum (on positron emission tomography [PET]1 and PET2) |
| Measure | Description | Time Frame |
|---|---|---|
| Renal 68Ga-PSMA-11 uptake | SUVmax and SUVmean in the kidneys will be measured with a spherical volume-of-interest with and without the administration of MSG interventions. SUVmax/kidneys will be calculated and a mean SUVmax/patient will be generated. Paired T-test will be used to determine statistical significance per salivary gland and per patient. | 2 measurements within 2 to 14 days maximum (on PET1 and PET2) |
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Inclusion Criteria:
Patient volunteer to undergo 2 PSMA PET/CT scans within 14 days
Histopathologically proven prostate cancer (PCa)
PSMA PET/CT indicated for :
Ability to understand a written informed consent document and the willingness to sign it
Ability to ingest 300 mL of fluid across 10 minute period
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremie Calais, M.D. | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41698328 | Derived | Nikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102. |
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| Computed Tomography | Procedure | Undergo PET/CT |
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| Gallium Ga 68-labeled PSMA-11 | Drug | Given IV |
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| Monosodium Glutamate | Dietary Supplement | Given PO |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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| Tumor 68Ga-PSMA-11 uptake | SUVmax and SUVmean in the visible tumor lesions will be measured with a spherical volume-of-interest with and without the administration of MSG interventions. SUVmax/tumor lesions will be calculated and a mean SUVmax/patient will be generated. Paired T-test will be used to determine statistical significance per salivary gland and per patient. | 2 measurements within 2 to 14 days maximum (on PET1 and PET2) |
| Saliva radioactivity concentration | Saliva radioactivity concentration will be compared with and without saliva stimuli. | 2 measurements within 2 to 14 days maximum (on PET1 and PET2) |
| Incidence of adverse events of MSG administration | Up to 6 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| C000622699 | 68Ga-DKFZ-PSMA-11 |
| D012970 | Sodium Glutamate |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D018698 | Glutamic Acid |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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